- Device
- Wolverine Coronary Cutting Balloon
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S111
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new ISO class 8 Cleanroom to support expansion of the Stent Delivery Catheter production unit.